William Pryor: “I have a letter from Donna Shalala, the Secretary of HHS, and I quote…”

On the recordJune 27, 1996

I have a letter from Donna Shalala, the Secretary of HHS, and I quote from the letter that has been distributed throughout the Senate this afternoon. Secretary Shalala says: It will be nearly impossible to meet the substantial investment requirement under the Hatch substitute. She concludes saying: It would be virtually impossible for a manufacturer to obtain FDA approval for a generic drug product during this transition period.

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William Pryor

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govinfo.gov

Editor's note · Context

Discussing concerns about the Hatch substitute related to FDA approval for generic drugs.

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William Pryor: “I have a letter from Donna Shalala, the Secretary of HHS, and I quote from the letter that has been distributed…”

Editor's note · Context